510(k) Report

Devices descending from K100618

339 later devices reach Maxlock Extreme Extremity Plating System with Variable Angle Technology through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+3K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+3K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+3K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+3K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+3K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+3K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+3K192356Airlock Centrolock Osteosynthesis Implant SystemNovastep20192—
+3K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+3K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+3K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+3K192504Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201910—
+3K191636APTUS Foot SystemMedartis AG20190—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+3K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+3K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+3K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+3K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+3K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+3K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+3K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+3K172886Breakaway Screw SystemParagon 2820174—
+3K172350AxSOS 3 TiStryker GmbH201717—
+3K172300CoLink View Plating SystemIn2bones USA, LLC201716—
+3K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+3K171510Footmotion Plating SystemNewclip Technics20171—
+3K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+3K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+3K170843Alians Fragment SpecificNewclip Technics20171—
+3K170012Foot and Hand MotionNewclip Technics20170—
+3K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+3K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+3K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+3K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+3K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+3K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+3K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+3K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+3K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+3K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+3K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+3K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+3K153531Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201611—
+3K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+3K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+3K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+3K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+3K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+3K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+3K143365Eminent Foot Plate SystemEminent Spine20151—
+3K150368Tarsa-Link Wedge Fixation SystemLife Spine201510—
+3K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+3K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+3K141992Variax 2 SystemStryker Trauma AG201422—
+3K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+3K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+3K123203Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc.201238—
+3K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+3K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201238—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K261191Alians Elbow SNewclip Technics20260—
+4K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+4K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+4K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+4K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+4K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+4K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+4K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+4K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+4K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+4K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+4K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+4K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+4K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+4K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+4K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+4K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+4K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—